BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 6133555 · Received November 29, 2016

    Report

    Report Number
    2523676-2016-00839
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Report Date
    July 9, 2015
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K042488
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS EVENT FIVE OF B. BRAUN MEDICAL INC. INTERNAL REPORT # (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, DUE TO THIS COMPLAINT AND OTHER CONFIRMED COMPLAINTS OF THIS NATURE, B. BRAUN MEDICAL HAS INITIATED A CORRECTIVE ACTION/ PREVENTATIVE ACTION (CAPA) (B)(4) TO ADDRESS THE ISSUE OF SHEARED/DAMAGED CATHETERS. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. NOTE: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE COP-QP-8000051.

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: EVENT 5. WHILE REMOVING A CATHETER IT BROKE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783398 PERIFIX® CATHETER, CONDUCTION, ANES BSO B. BRAUN MEDICAL INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1